Ventilated Patient Form Instructions - OPTN Process Data 0906-NEW 11202025

Process Data for Organ Procurement and Transplantation Network

Ventilated Patient Form Instructions - OPTN Process Data 0906-NEW 11202025

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OMB No. 0906-XXXX; Expiration Date: XX/XX/202X


Ventilated Patient Form Instructions

The purpose of the Ventilated Patient Form (VPF) is to collect demographic information and OPO process data on patients who:

  • have a documented Pronouncement of Death,

  • were ventilated during their terminal hospitalization, and

  • were referred to the OPO by a hospital or identified by the OPO while onsite at the hospital, or found by the OPO upon death record review as required by 42 CFR 486.348(b).


Definition

  • Required data field: A field is required only if it actually appears in the cascade flow of control per specific responses to previous questions. Furthermore, partial Ventilated Patient Form data can be collected and saved without completion of required data fields; however the form cannot be transmitted to HRSA and/or the OPTN until all required fields are completed.



Status: This field is read-only and displays Incomplete. It will only change to Complete once the record is successfully validated.


Hospital and OPO Data


DonorNet Donor ID: Enter the unique Donor ID and click Search. If this is a valid Donor ID, then many of the field values below can be copied from the Deceased Donor Registration (DDR) record to the same field in the VPF. In the VPF they will become read-only. All such "copied" fields are noted individually, below. If this is a patient record only (no DonorNet Donor ID), all fields need to be completed - nothing is copied.

OPO Record ID: If this is a patient with a Donor ID, the OPO Record ID from the donor record displays and is read-only. If this is a patient record only, enter the OPO Record ID. This is a required field.

OPO: If this is a patient with a Donor ID, the OPO from the donor record displays and is read-only. If this is a patient record only, select the OPO from the drop-down list. This is a required field.

Patient Hospital: If this is a patient with a Donor ID, the Hospital from the donor record (“Donor Hospital”) displays and is read-only. If this is a patient record only, select the Hospital from the drop-down list. Verify the hospital name and the Medicare provider number of the hospital that originally referred the patient or the hospital from which the patient was identified at death record review. A list of Medicare provider numbers for your state can be obtained in the Donor Hospitals section of DonorNet. This is a required field.

Demographic and Clinical Data

Last Name: If this is a patient with a Donor ID, the Last Name from the donor record displays and is read-only. If this is a patient record only, enter the patient’s Last Name. This is a required field.

First Name: If this is a patient with a Donor ID, the First Name from the donor record displays and is read-only. If this is a patient record only, enter the patient’s First Name. This is a required field.

Middle Initial: If this is a patient with a Donor ID, the Middle Initial from the donor record displays and is read-only. If this is a patient record only, enter the patient’s Middle Initial. This field is not required.

Note: If the donor identity is unknown, enter the hospital-generated alias.

Home Zip Code: If this is a patient with a Donor ID, the Home Zip Code from the donor record displays and is read-only. Enter the U.S. Postal Zip Code of the location where the patient lived before hospitalization. If Zip Code is unknown, select Unknown. Do not use the referring hospital zip code as a proxy when Zip Code is unknown. This is a required field.

Ethnicity: If this is a patient with a Donor ID, the Ethnicity from the donor record displays and is read-only. If this is a patient record only, select as appropriate to indicate the Ethnicity of the patient.


OMB defines ethnicity to be whether or not a person self-identifies as Hispanic or Latino. For this reason, ethnicity is broken out into two categories, (1) Hispanic or Latino or (2) Not Hispanic or Latino. Select one ethnicity category or select 'Ethnicity Not Reported' if a category was not self-identified by the person. 


This is a required field. 


Hispanic or Latino A person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race. 


Not Hispanic or Latino


Ethnicity Not Reported  Select if person did not self-identify an ethnicity category.


Race: If this is a patient with a Donor ID, the Race from the donor record displays and is read-only. If this is a patient record only, select as appropriate to indicate the Race of the patient.


An individual can select one or more race categories (1) White, (2) Black or African American, (3) Asian, (4) American Indian or Alaska Native, (5) Native Hawaiian or Other Pacific Islander, or Race Not Reported.


This is a required field.


Select one or more race sub-categories or origins.  Select 'Other Origin' if origin is not listed. Select 'Origin Not Reported' if the origin was not self-identified by the person.


White  A person having origins in any of the original peoples of Europe, the Middle East, or North Africa.


European Descent

Arab or Middle Eastern

North African (non-Black)

Other Origin

Origin Not Reported


Black or African American  A person having origins in any of the Black racial groups of Africa.


African American 

African (Continental)

West Indian

Haitian

Other Origin

Origin Not Reported 


American Indian or Alaska Native  A person having origins in any of the original peoples of North and South America (including Central America) and who maintains tribal affiliation or community attachment.


American Indian

Eskimo

Aleutian

Alaska Indian 

Other Origin

Origin Not Reported


Asian – A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam.


Asian Indian/Indian Sub-Continent

Chinese

Filipino

Japanese

Korean

Vietnamese

Other Origin

Origin Not Reported 




Native Hawaiian or Other Pacific Islander – A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.


Native Hawaiian

Guamanian or Chamorro

Samoan

Other Origin

Origin Not Reported


Race Not Reported Select if person did not self-identify a race category or origin.

Birth Sex: If this is a patient with a Donor ID, “Gender” from the donor record displays and is read-only. If this is a patient record only, select as appropriate to indicate the Birth Sex of the patient. Report donor sex (Male or Female), based on biologic and physiologic traits at birth. If sex at birth is unknown, report sex at time of referral as reported by patient or documented in medical record. The intent of this data collection field is to capture physiologic characteristics that may have an impact on recipient size matching or graft outcome. This is a required field.


Height: If this is a patient with a Donor ID, Height from the donor record displays and is read-only. If this is a patient record only, enter the height of the patient in ft (feet) and in (inches) or cm (centimeters). If the patient’s height is unavailable, select the reason from the status (ST) drop-down list (N/A, Not Done, Missing, Unknown). This is a required field.


Weight: If this is a patient with a Donor ID, Weight from the donor record displays and is read-only. If this is a patient record only, enter the first measured weight of the patient after hospital admission in lbs (pounds) or kg (kilograms). This is a required field. If the patient’s weight is unavailable, select the reason from the status (ST) drop-down list (N/A, Not Done, Missing, Unknown).

Age: If this is a patient with a Donor ID, Age from the donor record displays and is read-only. If this is a patient record only, enter the date the donor was born using the standard 8-digit numeric format of MM/DD/YYYY or enter the donor’s age in Years or Months. This is a required field.


Cause of Death: If this is a patient with a Donor ID, Cause of Death from the donor record displays and is read-only. If this is a patient record only, select the patient’s cause of death from the drop-down list. This is a required field.

If the cause of death is not listed, select Other Specify, and enter the cause of death in the Specify field. This is a required field.

Anoxia
Cerebrovascular/Stroke
Head Trauma
CNS Tumor
Other Specify

Mechanism of Death: If this is a patient with a Donor ID, Mechanism of Death from the donor record displays and is read-only. If this is a patient record only, select the patient’s mechanism of death from the drop-down list. If the mechanism of death is not listed, select None of the Above. This is a required field.

Drowning
Seizure
Drug Intoxication
Asphyxiation
Cardiovascular
Electrical
Gunshot Wound
Stab
Blunt Injury
SIDS
Intracranial Hemorrhage/Stroke
Death from Natural Causes
None of the Above

Circumstances of Death: If this is a patient with a Donor ID, Circumstance of Death from the donor record displays and is read-only. If this is a patient record only, select the patient’s circumstances of death from the drop-down list. If the circumstance of death is not listed, select None of the Above. This is a required field.

MVA
Suicide
Homicide
Child-Abuse
Accident, Non-MVA
Death from Natural Causes
None of the Above

Did patient legally document decision to be an organ donor?: If this is a patient with a Donor ID, “Did patient legally document decision to be a donor?” from the donor record displays and is read-only. If this is a patient record only, if the patient record had legal documentation of intent to be a donor, select Yes. If not, select No. If unknown, select Unknown. This is a required field.

If the selection is No or Unknown, cascades to Date and Time of Pronouncement of Death.

If the selection is Yes, cascades to First Person Authorization Restrictions.

First Person Authorization Restrictions: For each patient record with legal documentation of intent to be a donor, select any restrictions. OPOs should reference any document the OPO would consider applicable under their state laws. This is a required field.

Kidney

Pancreas

Intestine

Liver

Heart

Lung

Tissue (select if there are restrictions on any tissue, including ocular)

None


Date and Time of Pronouncement of Death: If this is a patient with a Donor ID, “Date and Time of Pronouncement of Death” from the donor record displays and is read-only. If this is a patient record only, enter the date, using the standard 8-digit numeric format of MM/DD/YYYY, and military time of pronouncement of death of the donor. This is a required field.

KDPI: For each patient record, provide the last calculation for the Kidney Donor Profile Index (KDPI) if available. This field is not required.


OPO Process Data

Case Detail/How did the OPO learn of this patient?: Select as appropriate to indicate how the OPO learned of this patient. This is a required field.

Hospital referral: A hospital referred the patient to the OPO or the OPO identified the patient while onsite at the hospital. This value initially displays.
Death record review: The OPO located the patient record upon review. Change to this value if applicable.

If the selection is Hospital referral, cascades to Date and Time of first hospital referral for terminal admission.

Date of First Hospital Referral for Terminal Admission: If this is a patient with a Donor ID, Referral Date from the donor record displays and is read-only. If this is a patient-record only, for each patient record referred by the hospital to the OPO, enter the date, using the standard 8-digit numeric format of MM/DD/YYYY. This is a required field.


Time of First Hospital Referral for Terminal Admission: For each patient record referred by the hospital to the OPO, enter the military time of referral. This is a required field. After this field, cascade to Did the OPO respond onsite at the hospital to the patient referral?


Else if the selection is Death record review, cascades to Date of death record review.

Date of death record review : For each patient record, enter the date of death record review, using the standard 8-digit numeric format of MM/DD/YYYY. This is a required field. After this field, cascade to Case Disposition (Terminal Step).



Did the OPO respond onsite at the hospital to the patient referral?: For each patient record, indicate whether the OPO responded onsite at the hospital to the patient referral by selecting Yes or No. This is a required field.


If the selection is No, cascades to Remote EMR Access.


If the selection is Yes, cascades to Date and Time of first OPO Onsite Response following referral.


Date and Time of first OPO Onsite Response following referral: For each patient record, enter the date, using standard 8-digit numeric format of MM/DD/YYYY, and the military time of OPO onsite response. This is a required field.


Remote EMR Access: For each referred patient, indicate whether the OPO had patient-specific electronic access to the referred patient’s hospital Electronic Medical Record (EMR) , by selecting Yes or No. This is a required field.



Patient Donation Pathway(s): For each patient record, select the category or categories of organ procurement for which the OPO followed the patient at any point prior to case close. This is a required field.

Donation after Circulatory Death (DCD)

Donation after Brain Death (DBD)

Both DCD and DBD

Neither


Note: If the patient was medically ruled out before being followed for procurement, select “Neither.”


Was the patient medically ruled out by the OPO prior to approach?: For each patient record, indicate whether the OPO determined- based on its internal medical rule-out criteria- that the patient was not suitable for organ procurement by selecting Yes or No. This is a required field.


If the selection is No, cascades to Method of Authorization Used by OPO.


If the selection is Yes, cascades to Case Disposition (Terminal Step).


Method of Authorization Used by OPO: If this is a patient with a Donor ID, the selection from “Method of authorization used” from the donor record displays and is read-only. If this is a patient record only, select whether the OPO identified First Person Authorization or Hierarchy authorization for the purposes of procurement. This is a required field.


If the selection is First Person Authorization, cascades to Was there a Legal Next of Kin (LNOK) objection to organ procurement with first person authorization?


If the selection is Hierarchy, cascades to Was there an approach for authorization for organ procurement?


Was there a Legal Next of Kin (LNOK) objection to organ procurement with first person authorization?: For each patient record, select Yes or No if there was a LNOK objection to first person authorization. This is a required field. Note: Please select yes if there was an objection, even if the objection was later resolved.


Was there an approach for authorization for organ procurement? For each patient record, select Yes or No if there was an approach for authorization for organ procurement. This is a required field.


If the selection is Yes, cascades to Date and Time of First OPO Hierarchy Approach for Authorization.


If the selection is No, cascades to Case Disposition (Terminal Step).


Date and Time of First OPO Hierarchy Approach for Authorization: For each patient record, enter the date, using standard 8-digit numeric format of MM/DD/YYYY, and the military time of first approach for authorization. This is a required field.


Modality of Approach: For each patient record, select modality of first OPO hierarchy approach for authorization from the drop-down list. This is a required field.


In-person

Phone

Video

Text (SMS)

Unknown


Language of Approach: For each patient record with an approach, select language(s) of first OPO hierarchy approach for authorization. This is a required field.


English

Spanish

Language other than English or Spanish


Interpreter Used in Approach: For each patient record with an approach, select whether OPO utilized interpretation or translation from any of the options on the drop-down list. This is a required field.


OPO staff

Patient family

Hospital

Third party service

Medical Translation Application

Other

None


Authorization: For each patient record with an approach, select the outcome from the drop-down list. This is a required field.


LNOK Authorized

LNOK Decline

Hospital Authorized

Hospital Declined


If the selection is LNOK Authorized or Hospital Authorized, cascades to Date and Time of Authorization for Procurement.


If the selection is LNOK Decline or Hospital Declined, cascades to Case Disposition (Terminal Step).


Date and Time of Authorization for Procurement: For each patient record, enter the date, using standard 8-digit numeric format of MM/DD/YYYY, and the military time of authorization of procurement. This is a required field.


Tissue Authorization: For each patient record, indicate whether any tissue procurement was authorized by selecting Yes, No, or Non-applicable from the drop-down list. This is a required field.


Terminal Step


Case Disposition: For each patient record, select the case disposition from the menu. Select all that apply. This is a required field.


Recovered Organ Donor


OPO Decline to Pursue Donation


First Person Authorization (FPA) Objection


Medical Rule Out


Procurement Denied by Medical Examiner/Coroner/Warden


Allocation Exhausted Prior to OR


Cardiac Arrest Prior to OR


Outside Expiration Time for DCD Recovery


Case Closed in OR Without Organs Recovered


Hospital Interference: For each patient record, select Yes or No if there is Hospital Interference. This is a required field.


If the selection is Yes, cascades to Describe Hospital Interference.


If the selection is No, cascades to Date and Time Case Close.


Describe Hospital Interference: For each patient record, indicate which hospital actions the OPO characterized as interference. This is a required field. Note: This field is intended to identify process improvement opportunities.


Ventilated Patient Not Referred to the OPO


Referral Made to OPO Outside of Timely Requirement


Unplanned Extubation After Referral Made to OPO


Hospital Blocked OPO Approach for Authorization


Reportable Interference:: For each patient record where the OPO identifies hospital interference (according to its internal policies), indicate whether the OPO determined if the interference was a reportable to the hospital, regardless of whether a donation ultimately occurred. Select Yes or No from the drop-down list. This is a required field. Note: OPOs should retain reporting and remediation documentation as follow-up may be required for quality improvement as per § 486.328.



Date and Time Case Close: For each patient record, enter the date, using standard 8-digit numeric format of MM/DD/YYYY, and the military time of OPO case close. This is a required field. This action completes the form. Note: Case close represents the point at which the OPO has completed all active management and evaluation activities for the case and no further clinical or authorization actions are expected, even if follow-up reporting or hospital quality documentation occurs later. Later error corrections will not change date and time of case close.


Public Burden Statement: The private, non-profit Organ Procurement and Transplantation Network (OPTN) collects this information in order to perform the following OPTN functions: to assess whether applicants meet OPTN Bylaw requirements for membership in the OPTN; and to monitor compliance of member organizations with OPTN Obligations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information collection is 0906-XXXX and it is valid until XX/XX/202X. This information collection is required to obtain or retain a benefit per 42 CFR §121.11(b)(2). All data collected will be subject to Privacy Act protection (Privacy Act System of Records #09-15-0055). Data collected by the private non-profit OPTN also are well protected by a number of the Contractor’s security features. The Contractor’s security system meets or exceeds the requirements as prescribed by OMB Circular A-130, Appendix III, Security of Federal Automated Information Systems, and the Departments Automated Information Systems Security Program Handbook. The public reporting burden for this collection of information is estimated to average 0.37 hours per response, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Information Collection Clearance Officer, 5600 Fishers Lane, Room 14NWH04, Rockville, Maryland, 20857 or [email protected].   



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